Nitazoxanide vs Probiotics in the Treatment of Acute Rotavirus Diarrhea in Children: A Randomized Single Blind Controlled Trial in Bolivian Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Duration of diarrhea
研究概览
简要总结
Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be clinically important in time of hospitalization and reduction of duration of diarrhea secondary to rotavirus?
详细描述
Nitazoxanide has demonstrated a cytoprotective effect against rotavirus, reducing duration time of diarrhea in comparison to placebo in previous studies. In the current study, based in those results, we design a randomized single-blind controlled trial, in order to asses the effectiveness of nitazoxanide and probiotics in comparison with a control group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 28 Days 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive stool sample for rotavirus test
排除标准
- •Severe malnourishment
- •Severe dehydration
- •History of diarrhea more than 3 days previous hospitalization
- •Use of antibiotics, probiotics or nitazoxanide 3 weeks before admission
- •Systemic infections
- •Severe chronic disease
- •Mixed enteric infections besides rotavirus
研究组 & 干预措施
1
This group will receive oral nitazoxanide preparation
干预措施: Nitazoxanide (Drug)
2
This group will receive a mix combination of probiotics
干预措施: Probiotic mix preparation (Drug)
3
This is the control group receiving only oral or systemic hydration solutions
干预措施: Oral hydration solutions (Other)
结局指标
主要结局
Duration of diarrhea
时间窗: Hours
次要结局
- Duration of hospitalization(hours)